• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2007 Revisions and Updates

  • 11/08/2007:
    In the Compliance Program Guidance Manual list, a new Medical Devices compliance program 7386.001 "Inspection and Field Testing of Radiation-Emitting Electronic Products" supersedes three withdrawn Programs:
    • 7386.001 "Inspection of Manufacturers of Laser Products,"
    • 7386.002 "Field Implementation of the Sunlamp and Sunlamp Products Performance Standard As Amended,” and
    • 7386.004 "Field Compliance Testing of Cabinet X-Ray Equipment."
  • 10/10/2007:
    Revised list to remove 1 clinical investigator from restricted list and added to restrictions removed list.
  • 09/14/2007:
    Revised list to remove one firm from the Application Integrity Policy List.
  • 08/1/2007:
    Revised list to remove 1 clinical investigator from restricted list and added to restrictions removed list.
  • 07/13/2007
    CPG Manual Revised; "Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)", amended to incorporate the current references and cites to the Device Quality System Regulation (21 CFR Part 820)
  • 06/28/2007:
    Contact information updated for a series of BIMO pages.
  • 06/01/2007:
    Compliance Program Guidance Manual, Program 7361.003 "OTC Drug Monograph Implementation" is now on-line in a revised version. Program 7363.001 "Fraudulent Drugs" is reestablished on-line. Programs 7329.001 "Domestic Cosmetics Program" and 7329.002 "Imported Cosmetics Program" are combined into revised program 7329.001 "Cosmetics Program - Domestic and Imports"
  • 04/27/2007:
    In the Regulatory Procedures Manual March 2007, updated Chapter 4 (Advisory Actions) with revisions to Exhibit 4.1
  • 04/16/2007:
    Revised Debarment List, 04/16/2007 - One person added.
  • 03/28/2007:
    March 2007 edition of the Regulatory Procedures Manual (RPM) published; chapters 1, 4, 5, 6, 10 and 11 updated.
  • 01/23/2007:
    Revised list to add 1 new member, Restricted List for Clinical Investigators